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Claims for Patent: 6,399,101

Claims for Patent: 6,399,101

Title:

Stable thyroid hormone preparations and method of making same

Abstract:

Provided is a pharmaceutical preparation of thyroid hormone and a process of making a tablet formulation of the pharmaceutical preparation using direct compression. In a preferred embodiment, the pharmaceutical preparation comprises levothyroxine sodium and silicified microcrystalline cellulose.

2. The preparation of claim 1, further comprising a disintegrant and a lubricant.

3. The preparation of claim 2, wherein the disintegrant is sodium starch glycolate.

4. The preparation of claim 2, wherein the lubricant is magnesium stearate.

5. A stabilized pharmaceutical preparation comprising a stabilizing matrix consisting essentially of silicified microcrystalline cellulose and a therapeutically effective amount of levothyroxine sodium particles, which particles are captured and
protected within the stabilizing matrix.

6. The preparation of claim 5, further comprising a disintegrant, a lubricant and a coloring agent.

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